E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization of healthy people against influenza virus infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059430 |
E.1.2 | Term | Influenza immunization |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination inhibition (HI) test 21 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96. |
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E.2.2 | Secondary objectives of the trial |
Secondary immunogenicity objectives
a) To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 120 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.
b) To assess non-inferiority of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens against FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in terms of post-immunization GMTs as measured by HI test 21 and 120 days after vaccination.
Safety and tolerability objective
To evaluate the safety of the administration of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects eligible for enrolment into this study are:
- male and female adult volunteers aged 18 years or older,
- mentally competent,
- able to understand and comply with all study requirements,
- willing and able to give written informed consent prior to initiation of study procedures,
- in good health (as determined by clinical judgement of the investigator on the basis of medical history and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known, adequately treated, clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study.
• Female subjects aged 18 to 60 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study.
• Absence of existence of any exclusion criteria. |
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E.4 | Principal exclusion criteria |
• Pregnancy, breast-feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
• Hypersensivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;
• History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;
• History of Guillain-Barré syndrome;
• Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
• Immunosuppressive therapy within the past 36 months;
• Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
• Receipt of immunostimulants;
• Receipt of parenteral immunoglobulin, blood products and/or plasma derivates within the past 3 months;
• Suspected or known HIV, HBV or HCV infection;
• Acute disease and/or axillary temperature ≥37oC within the past 3 days;
• Vaccine therapy within the past 4 weeks;
• Influenza vaccination (any kind) within the past 6 months;
• Experimental drug therapy within the past 4 weeks;
• Concomitant participation in another clinical study;
• Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;
• Past or current psychiatric disease of the subject that upon judgement of the investigator may have effect on the objective decision-making of the subject;
• Alcohol or drug abuse of the subject. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To justify immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination inhibition (HI) test 21 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
21 days following vaccination. |
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E.5.2 | Secondary end point(s) |
Secondary immunogenicity end points:
a) To justify immunogenicity of one 0.5 mL intramuscular (IM) injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 120 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.
b) To justify non-inferiority of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens against FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in terms of post-immunization GMTs as measured by HI test 21 and 120 days after vaccination.
Safety and tolerability end point:
To justify the safety of the administration of one 0.5 mL IM injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary immunogenicity end points:
21 days and 120 days following vaccination.
Safety and tolerability end point:
Local and systemic reactions and other adverse events will be collected throughout the study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |